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cobas® Cdiff

Help stop the spread

Product image for cobas® Cdiff
See C. diff sooner, start patient care faster

The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is a real-time PCR test that provides accurate, on-demand results in 20 minutes for the detection of toxigenic C. diff in unformed stool specimens from patients suspected of having a C. diff infection (CDI).

 

cobas® Cdiff

 

  • Empowering faster informed isolation precautions with results in just 20 minutes
  • Reducing the risk of missing an acute infection with enhanced toxigenic C. diff strain coverage
  • Expanding C. diff testing beyond the lab with complete cobas® Liat® System connectivity

 

The cobas® Liat® System is uniquely designed to deliver the total point-of-care PCR solution, standardizing connected PCR testing closer to the patient and driving cost improvements across the health network.

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cobas® Cdiff performance

 

Cdiff

 

LOD: 90 CFU/swab

Sensitivity*

cobas CDIFF graph A

(95% CI: 88.1% - 96.5%)

Specificity*

cobas CDIFF graph B

(95% CI: 94.6% - 97.7%)

*Compared to direct culture
CI=confidence intervals. CFU=colony forming units.

product scan

 

 

Traditional diagnostic methods are either time-consuming, labor-intensive or inaccurate when used alone. Testing algorithms have been developed to overcome the shortcomings of individual methods. However, these algorithms are complex and can introduce delays in result reporting, which may adversely impact patient management.2

 

Traditional testing methods vs. cobas® Liat® System

 

Traditional testing
methods
chart_col_A_1_CDIFF

Patient with CDI symptoms

chart_col_A_2_CDIFF

Isolate

chart_col_A_3_CDIFF

Collect sample and send to lab

chart_col_A_4_CDIFF

Process with lab PCR or algo EIA

chart_col_A_5_CDIFF

Positive results: initiate antibiotics
Negative results: admit patient without
isolation and search for symptom etiologies

cobas® Cdiff
test
chart_col_C_1_CDIFF

Patient with CDI symptoms

chart_col_A_3_CDIFF

Collect sample and send to lab

chart_col_C_3_CDIFF

The cobas® Liat® System provides
accurate results in only 20 minutes

chart_col_C_4_CDIFF

Positive results: isolate and initiate antibiotics
Negative results:, admit patient without
isolation and search for symptom etiologies

Relying on the fast, accurate results from cobas® Cdiff, healthcare professionals are now able to streamline CDI diagnosis to reduce unnecessary isolation, empiric use of antibiotics and to initiate appropriate infection control measures.

 

 

See C. diff sooner

with cobas® Cdiff to transform your patient care pathway.

Learn more about the expanding menu of assays

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    ...
    cobas® Liat® System

    cobas® Liat® System

    Rapidly test, triage, and treat your patients with the accuracy, simplicity, and security needed at the point of care.

    mPOC total point-of-care PCR solution visual

    Total commitment deserves the total point-of-care PCR solution

    Elevating care across your POC testing ecosystem

    The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is an automated, qualitative in vitro diagnostic test that uses real-time polymerase chain reaction (PCR) for the detection of the toxin B (tcdB) gene of toxigenic Clostridioides difficile in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI). The cobas® Cdiff Nucleic acid test for use on the cobas® Liat® System is intended for use as an aid in the diagnosis of CDI in humans in conjunction with clinical and epidemiological risk factors.
    The cobas® Liat® System is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

    CE-IVD, FDA 510(K) cleared

    The cobas® Liat® System is commercially available in select markets. This product is not registered as an in vitro diagnostic (IVD) in all countries; additional information may be available from your Roche sales representative.

     

    Access package inserts through your country’s Roche Diagnostics Website.

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    References

    1. https://cdifffoundation.org/2014/11/24/c-difficile-infection-cdi-european-clinician-consensus-report-with-recommendations-for-improved-management-of-cdi, accessed on Feb 28, 2021.
    2. Gupta A, et. al. Extraintestinal Clostridium difficile infections: a single-center experience. Mayo Clin Proc. 2014 Nov;89(11):1525-36. doi: 10.1016/j.mayocp.2014.07.012. Epub 2014 Sep 20. PMID: 25245597.
    3. cobas® Cdiff [package insert], Pleasanton, CA; Roche Molecular Systems, Inc., 2021

    Specifications

    • Clinical sensitivity*

      93.5 % (95% CI 88.1% - 96.5%)

    • Clinical specificity*

      96.4 % ( 95% CI 94.6% - 97.7 %)

    • Analytical sensitivity (LoD)

      90 CFU/ Swab

    • Analytical specificity

      No cross-reactivity with 149 closely related organisms or organisms typically found in stool specimens

    • Positive agreement**

      96.0 % (95% CI: 91.6% - 98.2%)

    • Negative agreement**

      99.1 % (95% CI: 98.0% - 99.6%)

    • Assay target region

      C. difficile Toxin B (tcdB)

    • Strain coverage***

      37 toxigenic strains tested

    • Sample type

      Unformed stool in cobas® PCR Media

    • Technology

      Real-time PCR

    • Internal control

      Yes

    • Contamination control

      AmpErase

    • Reagents

      Ready-to-use, pre-packaged reagent assay tube format

    • Time to result

      20 minutes

    * Compared to direct culture

    ** Compared to a commercially available state-of-the-art NAAT

    *** All known C. difficile (Toxinotypes 0 ~ XXXI, except non-Toxigenic Toxinotypes XI), including the BI/NAP1/027 hyper-virulent epidemic strain

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